e-Gazette statutory gazette instrument G.S.R. 51(E) · 23 Jan 2026
Official title
Proposal for providing suitable provision under Drugs Rules, 1945 for inclusion of warning caution in blue colour strip box on the label of antimicrobials
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Check the official recordThe Ministry of Health and Family Welfare proposes an amendment to the Drugs Rules, 1945. The draft rule requires manufacturers of antimicrobial drugs and their preparations to include a conspicuous blue vertical strip on the left side of the product label. This strip must run throughout the body of the label without obscuring other mandatory information. The government invites public objections and suggestions regarding this proposal. Interested parties must submit their feedback within thirty days from the date the Gazette of India containing these draft rules becomes available to the public. Submissions may be sent by post to the Under Secretary (Drugs) in New Delhi or via email to the provided address.
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489 GI/2026 (1)
रजिस्ट्री सं. डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण् ड (i) PART II—Section 3—Sub-section (i) प्राजधकार से प्रकाजित PUBLISHED BY AUTHORITY स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसूचना नई दिल्ली, 21 िनवरी, 2026 सा.का.जन. 51(अ).—औषजध जनयम, 1945
में आगे संिोधन करने के जलए कुछ जनयमों का जनम्नजलजखत प्रारूप , जिसे केंद्र सरकार, औषजध और प्रसाधन सामग्री अजधजनयम, 1940
( 1940
का
23 ) की धारा 12
धारा ) 1 ( और
धारा 33
धारा ) 1 ( द्वारा प्रित्त िजियों का प्रयोग करते हुए, औषजध तकनीकी सलाहकार बोडड से परामिड के बाि, बनाने का प्रस्ट्ताव करती है, एतद्द्वारा उन सभी व्यजियों की सूचना के जलए प्रकाजित दकया िाता है जिनके इससे प्रभाजवत होने की संभावना है, और एतद्द्वारा सूजचत दकया िाता है दक उि प्रारूप जनयमों पर भारत के रािपत्र की प्रजतयां जिनमें ये प्रारूप जनयम िाजमल हैं, िनता के जलए उपलब्ध कराए िाने की तारीख से तीस दिन की अवजध समाप्त होने पर या उसके बाि जवचार दकया िाएगा। उपयुडि जनर्िडष्ट अवजध के भीतर दकसी भी व्यजि से प्राप्त होने वाली आपजत्तयों और सुझावों पर केंद्र सरकार द्वारा जवचार दकया िाएगा। आपजत्तयां और सुझाव, यदि कोई हों, अवर सजचव ) औषजध(, स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत सरकार, यू-6, वकड हॉल सी ववंग, प्रथम तल, कतडव्य भवन-1, नई दिल्ली, 110001
को संबोजधत दकया िा सकता है अथवा ई-मेल के माध्यम से drugsdiv-mohfw@gov.in पर भेिा िा सकता है। सं. 51] नई दिल्ली, बृहस्ट् पजतवार, िनवरी 22, 2026/माघ 2, 1947 No. 51] NEW DELHI, THURSDAY, JANUARY 22, 2026/MAGHA 2, 1947 सी.जी.-डी.एल.-अ.-23012026-269542 CG-DL-E-23012026-269542
2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] प्रारूप जनयम
जनयम )
MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, 21st January, 2026 G.S.R. 51(E).—The following draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub- section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001 or emailed at drugsdiv-mohfw@gov.in. DRAFT RULES
(i) These rules may be called the Drugs (...... Amendment) Rules, 2025. (ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette.
In the Drugs Rules, 1945, in Rule 96, in sub-rule (1), after clause (xiii), following clause shall be inserted, namely:– “(xiv) Antimicrobial drugs and their preparations shall bear a conspicuous blue vertical strip on the left side running throughout the body of the label without disturbing the other conditions printed on the label.” [F. No. X.11014/14/2025-DR] HARSH MANGLA, Jt. Secy. Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated 21st the December, 1945 and last amended vide notification number G.S.R.…..(E), dated.……
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054. GORAKHA NATH YADAVA Digitally signed by GORAKHA NATH YADAVA Date: 2026.01.23 16:00:04 +05'30'
